Efficacy and Safety of Azithromycin and Artesunate in Pregnant Women

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ClinicalTrials.gov Identifier: NCT00287300

Recruitment Status : Completed

First Posted : February 6, 2006

Last Update Posted : February 6, 2006

Sponsor:

Collaborator:

Centers for Disease Control and Prevention

Information provided by:

University of North Carolina, Chapel Hill

Study Description

Brief Summary:

The purpose of this study is to compare the efficacy and safety of three treatment regimens for the prevention of malaria during pregnancy.

Condition or disease	Intervention/treatment	Phase
Malaria	Drug: Sulfadoxine-Pyrimethamine Drug: Azithromycin Drug: Artesunate	Not Applicable

Detailed Description:

Malaria infection during pregnancy poses substantial risk to the mother, her fetus, and the neonate. Prevention of malaria during pregnancy is vital in decreasing maternal and child mortality in Africa. There are data from studies that show that intermittent preventive treatment (IPT) with two doses of sulfadoxine-pyrimethamine (SP) is safe, efficacious, and effective in preventing maternal anemia, placental parasitemia, and LBW. Resistance to SP, however, is increasing rapidly in Africa and there is an urgent need to find alternative effective, safe and affordable drugs for the treatment and prevention of malaria in pregnancy.

The investigators conducted a trial to determine the efficacy and safety of azithromycin and artesunate combined with sulphadoxine-pyrimethamine as treatment against malaria during pregnancy.Pregnant women 14 to 26 weeks gestation with P. falciparum parasitemia on peripheral blood film were randomly assigned into 3 treatment groups and received two doses of:(1) SP (3 tablets) only; (2) SP and azithromycin (1gram/day x 2 days)and (3) SP and artesunate 200mg/day for 3 days). The two doses of the study drug were administered approximately 4 weeks apart. All study drugs were taken under observation.Blood samples were collected on days 1, 2, 3, 7 and 14 after treatment and at any visit when the women presented with symptoms of malaria. The women were also given an insecticide-treated net (ITN) and followed until delivery. Adverse effects were assessed at each scheduled visit, any unscheduled visits during the study, and at delivery. Peripheral and placental blood films and placental biopsies were prepared at delivery. Newborns were weighed, examined, and gestational age was determined.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	141 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	A Pilot Randomized Controlled Trial of Azithromycin or Artesunate Added to Sulphadoxine Pyrimethamine as Therapy for Malaria in Pregnancy
Study Start Date :	September 2003
Study Completion Date :	August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Drug Information available for: Pyrimethamine Azithromycin Azithromycin dihydrate Azithromycin monohydrate

Genetic and Rare Diseases Information Center resources: Malaria

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

Parasitological failure rates
Parasite clearance time
Fever clearance times
Incidence rate of adverse events

Secondary Outcome Measures :

Prevalence rate of abortions
Prevalence rate of still births
Prevalence rate of peripheral parasitemia at delivery
Prevalence of placental malaria (thick blood film and histology)
Prevalence rate of maternal anemia

Eligibility Criteria

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Ages Eligible for Study:	15 Years to 49 Years (Child, Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

peripheral malaria parasitemia
signed informed consent
age 15-49 years
mother has felt the movements of the foetus (quickening)
fetal age of at least 14 but not more than 26 completed gestation weeks
maternal availability for follow-up during the entire period of the study

Exclusion Criteria:

known maternal tuberculosis, diabetes, kidney disease, or liver disease
mental disorder that may affect comprehension of the study or success of follow-up
twin pregnancy
pregnancy complications evident at enrollment visit (moderate to severe oedema, blood Hb concentration < 7 g / dl, systolic blood pressure (BP) > 160 mmHg or diastolic BP > 100 mmHg)
prior receipt of azithromycin during current pregnancy
receipt of any antimalarial within 28 days before enrollment
known allergy to drugs containing sulfonamides, macrolides or pyrimethamine
history of anaphylaxis
history of any serious allergic reaction to any substance, requiring emergency medical care
history of hepatitis or jaundice
concurrent participation in any other clinical trial

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00287300

Locations

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Malawi
Mpemba and Madziabango Health Centers
Blantyre, Malawi

Sponsors and Collaborators

University of North Carolina

Centers for Disease Control and Prevention

Investigators

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Principal Investigator:	Steve R Meshnick, M.D., Ph.D.	2. Department of Epidemiology, School of Public Health, University of North Carolina, Chapel Hill NC USA
Principal Investigator:	Stephen J Rogerson, MB BS, Ph.D.	3. Department of Medicine, University of Melbourne, Royal Melbourne Hospital, Parkville Victoria Australia
Principal Investigator:	Marjorie Chaponda, MB BS, MPH	1. UNC Malaria Project, Department of Community Health, College of Medicine, University of Malawi

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kalilani L, Mofolo I, Chaponda M, Rogerson SJ, Alker AP, Kwiek JJ, Meshnick SR. A randomized controlled pilot trial of azithromycin or artesunate added to sulfadoxine-pyrimethamine as treatment for malaria in pregnant women. PLoS One. 2007 Nov 14;2(11):e1166.

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ClinicalTrials.gov Identifier:	NCT00287300
Other Study ID Numbers:	03-EPID-153
First Posted:	February 6, 2006 Key Record Dates
Last Update Posted:	February 6, 2006
Last Verified:	January 2006

Keywords provided by University of North Carolina, Chapel Hill:


Malaria Pregnancy Efficacy Azithromycin Artesunate

Additional relevant MeSH terms:

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Malaria Protozoan Infections Parasitic Diseases Azithromycin Artesunate Pyrimethamine Sulfadoxine Fanasil, pyrimethamine drug combination Anti-Bacterial Agents Anti-Infective Agents Antimalarials Antiprotozoal Agents	Antiparasitic Agents Antineoplastic Agents Antiviral Agents Schistosomicides Antiplatyhelmintic Agents Anthelmintics Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Infective Agents, Urinary Renal Agents

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